Randomized Anticoagulation Trial in Opcab (RATIO) (RATIO)

May 11, 2017 updated by: Michele Triggiani, Azienda Ospedaliera di Lecco

High Dose Versus Low Dose Heparinization in Patients Undergoing Offpump Coronary Artery Bypass

The RATIO Study is a multicenter, nationwide, randomized, controlled, single blinded, unfunded trial of n. 900 patients undergoing multivessel OPCAB (≥2 grafts). This study is designed to test in patients undergoing off-pump coronary artery bypass surgery the hypothesis that full (high dose, 300 U/kg) and half (low dose,150 U/kg) heparinization are not different in terms of thrombotic complications and major perioperative bleeding events (null hypothesis).

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

Off-pump coronary artery bypass grafting (OPCAB) is an established alternative to on-pump coronary artery bypass grafting (CABG). OPCAB determines a pro-coagulant state potentially deleterious on grafts patency, that is not counterbalanced by the adverse effects of cardiopulmonary bypass on coagulation occurring in CABG, and that lasts as long as one month. Therefore in OPCAB systemic heparinization is necessary to prevent thrombotic complications during transitory occlusion of coronary arteries and grafts. An internationally accepted standard intra-operative anticoagulation protocol for OPCAB has not yet been defined, and heparinization in OPCAB is a highly variable practice. The intraoperative anticoagulation regimen adopted in patients undergoing OPCAB may influence major postoperative outcomes, such as bleeding, transfusion requirements, inflammatory response, myocardial ischemia and grafts patency, but it has never been the object of large-scale randomized controlled trial (RCT). The 2 most widespread intraoperative anticoagulation protocols in OPCAB are represented by full (300 U/kg) or half (150 U/kg) heparinization, with target ACT ranging from 200 sec to >480 sec.

Patients enrolled in the study will be randomized to receive full or half heparinization in a 1:1 ratio using a randomization schedule blocked by site. Randomization will take place in the operatory room by the anesthesiologist, and will be blinded to the surgeon.

Study Type

Interventional

Enrollment (Anticipated)

900

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • Jilin Heart Hospital
        • Contact:
        • Principal Investigator:
          • Massimo Lemma, MD
      • Lecco, Italy, 23900
      • Sassari, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria di Sassari
        • Contact:
        • Principal Investigator:
          • Michele Portoghese, MD
        • Sub-Investigator:
          • Francesco Massi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Consecutive patients electively undergoing multivessel OPCAB

Exclusion Criteria:

Acute coronary syndrome, on-going double anti-platelets treatment (the second antiplatelet drug should be suspended 5 days before surgery), on-going intravenous heparin or sub-cutaneous low molecular weight heparin, known coagulopathy, documented liver disease, chronic renal failure (creatinine ≥ 2 mg/dl) or previous renal transplantation surgery, previous cardiac surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: half heparinization
heparin I.V. 150 U/kg
Active Comparator: full heparinization (300 U/kg)
heparin I.V. 300 U/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite vascular
Time Frame: 30 days post-operatively
Death from vascular causes, perioperative myocardial infarction, stroke.
30 days post-operatively
Composite major bleeding
Time Frame: 48 hours post-operatively
Redo for excessive bleeding, cardiac tamponade, transfusion ≥3 Units of packed red cells or of platelets.
48 hours post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative bleeding
Time Frame: 48 hours post-operatively
Total bleeding evaluated the morning after surgery (ml.)
48 hours post-operatively
Transfusion of packed red cells (<3 Units) or of platelets
Time Frame: 30 days post-operatively
30 days post-operatively
Peak value of cardiac biomarker
Time Frame: 30 days post-operatively
30 days post-operatively
Transient ischemic cerebral attack
Time Frame: 30 days post-operatively
30 days post-operatively
Mesenteric ischemia (angiography or CT scan)
Time Frame: 30 days post-operatively
30 days post-operatively
Pulmonary embolus (angiography or CT scan)
Time Frame: 30 days post-operatively
30 days post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michele NR Triggiani, MD, PhD, ASST Lecco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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